Amplified Fed-Batch Process Renovating Biotech Production Landscape
In a groundbreaking development for the biopharmaceutical industry, a shift towards intensified fed-batch processing is set to transform upstream bioprocessing. This game-changing approach, as discussed by Yuxin Liu, a senior scientist at Merck KGaA, at the Bioprocess International Conference in Boston, promises to accelerate clinical pipelines, shorten timelines for early market access, and provide a stronger path to market for biologics.
The new feed formulations and streamlined feeding strategy in intensified fed-batch signal more than incremental progress. They represent a significant leap forward, offering increased productivity (up to 10 times), reduced production costs, and a potential decrease in facility size.
At the heart of this revolution is a shift from daily volume-by-cell-density (VCD)-based adjustments to a fixed-volume feeding strategy. This change not only boosts yields but also simplifies operations by eliminating the need for daily cell counts and reducing variability across runs. The fixed-volume feeding strategy also allows teams to know exactly how much feed to add from the start, reducing uncertainty in the process.
The streamlined feeding strategy in intensified fed-batch further eliminates daily sampling and adjustments, saving time, cutting labor, and improving reproducibility at scale. This simplification of operations is a key benefit of the new approach, making it more accessible for manufacturing teams.
Liu's research indicates that intensified fed-batch processing can lead to increased titers (up to 18 g/L) in a shorter period (14 days) compared to conventional fed-batch. This increase in productivity is achieved through the use of new feed formulations, optimized for high-density cultures, with improved amino acid profiles, added nucleotides, and antioxidants, and a better redox balance.
The game-changing shift in upstream bioprocessing through intensified fed-batch also has the potential to lower costs and reduce facility footprints. By moving from daily VCD-based adjustments to a fixed-volume feeding strategy, operations become more streamlined, further reducing costs.
In conclusion, intensified fed-batch processing, as presented by Liu, offers a promising solution for biologics developers. It promises faster development, higher efficiency, and a more cost-effective and streamlined production process. This revolution in bioprocessing is set to reshape the biopharmaceutical industry, providing a stronger path to market for biologics and faster access to life-saving treatments for patients worldwide.
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